An NIH panel is currently reviewing ways in which it can implement changes to policies allowing chimpanzees in biomedical research as recommended last December by the Institute of Medicine (IOM) and National Research Council of the National Academies. The recommendations limit the extent to which the agency can support research that involves chimpanzees.

NIH issued a formal Request for Information (RFI), seeking public comment on the recommendations, which had a deadline of today, April 10. A spot-check of the federal regulatory public document website Regulations.gov turned up no public comments in response to the RFI, but the Federation of American Societies for Experimental Biology (FASEB) did send a letter to the NIH in response to the RFI.

In the meantime NIH has created a nine-member working group to offer advice on how to carry out IOM’s guiding principles. NIH’s Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research will offer suggestions on which current studies meet IOM standards, how to close studies that do not comply with the IOM recommendations, and how to regulate the size and placement of research-active and -inactive populations of NIH-owned or -supported chimpanzees. Additionally, the working group will develop a review process for considering whether future use of the chimpanzee in NIH-supported research is scientifically necessary and consistent with the IOM principles.

The working group is expected to deliver a public update on June 5, with policy recommendations likely to come in a final report to be submitted early next year. “They’re going to give us an overall checklist: If you’re going to implement this, here are the issues that you have to consider,” James M. Anderson, M.D., Ph.D., director of the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), told GEN.

Setting Up New Rules

Approving new research will entail some form of additional scrutiny by a review panel. “What we envision here is an additional step by a group whose characteristics would be described by the working group,” Dr. Anderson explained. “That will probably lead to fewer grants being funded, and we guess that’s about half of the current ones.”

The IOM report noted that 937 chimpanzees were housed at five facilities as of October 2011. However, that figure includes chimps not owned or supported by NIH, such as those housed at the New Iberia Research Center and Yerkes National Primate Research Center as well as 120 chimps that are retired. The number of NIH-owned or supported chimps in research is closer to 730, according to Harold L. Watson, Ph.D., director of the NIH Chimpanzee Management Program.

In comments submitted April 5, FASEB noted that many of the chimps to be transitioned to inactive status will be aged and have chronic medical conditions. “While research facilities generally have large veterinary staffs, extensive clinic and hospital facilities, and sophisticated diagnostic pathology laboratories, most sanctuaries in the United States do not have the staff or infrastructure to care for animals with chronic conditions,” FASEB’s president, Joseph C. LaManna, stated in a letter. Most sanctuaries also aren’t subject to regulation under the Animal Welfare Act, he added.

For example, the National Chimpanzee Sanctuary at Chimp Haven is the only sanctuary able to care for chimpanzees exposed to viruses such as HIV and hepatitis, but “there have been occurrences when the sanctuary has declined to accept from research facilities chimpanzees with diabetes because it did not have the staff or veterinary expertise to provide the care that these chimpanzees would require on a daily basis.”

FASEB recommended several categories of professionals be represented on the oversight committee NIH envisions would review future research proposals: At least one laboratory animal veteran, a primatologist, a bioethicist, an Institutional Review Board official, a public health official, a virologist, an immunologist, a social scientist/neuroscientist, a geneticist, and a technology expert.

“The oversight committee should also include those who are knowledgeable about the availability and utility of alternative technologies to the use of chimpanzees, such as in vitro, nonhuman in vivo, or other research models,” LaManna wrote.

Are Captive Chimps an Endangered Species?

While the NIH may not have received as many comments in response to its RFI, plenty of public comment has been filed in response to another proposed rule change affecting chimpanzees. The U.S. Fish & Wildlife Service (FWS) is reviewing whether to amend the designation of captive chimps from “threatened” to “endangered,” which would protect them under the Endangered Species Act (ESA). Current law distinguishes between captive chimps and wild chimps, with only the latter protected as endangered species. FWS launched a review of the status of chimps last September following a petition by six groups.

If the petition is granted, “it would make research a lot more difficult,” Dr. Watson said. “It would become difficult to request samples like blood samples or tissues from deceased animals, and the only type of research theoretically that would be freely allowed would be research that directly benefits chimpanzees. And of course, the research that we do now is aimed mainly at humans. But some does benefit chimpanzees.”

According to the IOM report, 110 NIH-sponsored projects between 2001 and 2010 involved chimpanzee research: 44 in hepatitis, 13 comparative genomics projects, 11 were neuroscience studies, nine were in AIDS/HIV, seven were for behavioral research, and the rest in areas such as malaria, respiratory syncytial virus, and projects supporting chimpanzee colonies. “While the chimpanzee has been a valuable animal model in past research, most current use of chimpanzees for biomedical research is unnecessary,” the report declared.

A majority of commenters to FWS agreed with the petition, contending that all five of the agency’s factors for endangered status were met by captive chimpanzees: They have been exploited for food, entertainment, personal property, and research; they have encountered disease through research and natural behavior contact with humans; wild chimp populations fell by about two-thirds during the 35 years FWS has distinguished between captive and wild chimps; they are inadequately protected by existing law; and their plight harms wild chimpanzees by minimizing the threat to their survival.

“Chimpanzees in laboratories live in a constant state of stress, under the relentless threat of physically invasive research protocols,” remarked Jane Goodall, Ph.D., founder of the Jane Goodall Institute. “It is ironic that much of this research involves investigation of diseases of the immune system, such as HIV/AIDS. Yet, the response of the immune system to a particular treatment may be skewed if the system is stressed.

“This experimentation, when our closest living relatives are often treated as nothing more than inconveniently strong and potentially aggressive guinea pigs, certainly does not foster respect for the chimpanzee species and as such does not promote conservation,” Dr. Goodall added. She noted that the U.S. was the only nation actively involved in invasive biomedical research on captive chimpanzees.

Instead of keeping chimpanzees in research labs, Dr. Goodall commented, “science can benefit greatly from obtaining data in a noninvasive manner from wild chimpanzees living in protected areas and sanctuaries across Africa.”

Aligning Reclassification with New Biomedical Rules

The National Association for Biomedical Research (NABR), however, has urged FWS to follow NIH in implementing IOM’s recommendations. It pointed to IOM’s resistance to banning chimp research outright as reclassification supporters seek.

NABR cited IOM’s exceptions to continue using chimps in research for prophylactic HCV vaccines, mAb, comparative genomics, and behavioral disorders. IOM also stated, “A new, emerging, or reemerging disease or disorder may present challenges to treatment, prevention, and/or control that defy nonchimpanzee models and available technologies and therefore may require the future use of the chimpanzee.

“Many of the contributions made over the last thirty years would not have been possible if captive chimpanzees had been listed as endangered,” NABR added. “Chimpanzees have made invaluable contributions to science and medicine, including the development of vaccines for hepatitis A and B. Chimpanzees have helped scientists gain insights into diseases such as hepatitis C, malaria, HIV/AIDS, human cytomegalovirus infection, and cancer.”

Given FWS’ willingness to take on an issue spearheaded by animal-rights interests and the preponderance of advocates for reclassification, the agency is likely to eventually approve redesignating captive chimps as endangered. In that circumstance, supporters of biopharma chimpanzee research will consider moving their work outside the U.S. to nations offering weaker animal-protection laws; China’s first animal-protection law remains a proposal three years after it was introduced.

Supporters of using chimpanzees in research will also be looking forward to the likelihood that NIH’s new policies will enable continued funding at least in some human diseases and for research that can be said to benefit chimps.

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